The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Nuclear Regulatory Commission issues advisory letter to INIS; HHS authorizes pharmacy interns to test for COVID-19.
With more than two months left in 2020, it is imminently clear that the $147.3 billion in biopharma projected deal values will likely rise above last year’s record of $160.3 billion, considering the average value per month more than covers the gap. Mergers and acquisitions are currently tracking in fifth place over the past seven years with projected values at $134.7 billion.
HONG KONG – Even with vaccine administration just around the corner, Indonesian President Joko Widodo has warned his ministers to not rush the launch of COVID-19 vaccines over mounting public concerns about whether those vaccines would be certified halal, or permissible under Islamic law.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascendis, Astrazeneca, Evgen, Kezar.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allarity, Astrazeneca, Bayer, BMS, Curevac, Entos, Gilead, Immunomedics, Innate, Innocan, KBP, Medicago, Nicox, Orphazyme, Precision Nanosystems.
With the lack of public trust and confidence the biggest barrier to SARS-CoV-2 vaccines in the U.S., the risk of granting an emergency use authorization to a vaccine with safety issues or questionable efficacy could destroy confidence in future FDA-approved products. That message was drummed home throughout the Oct. 22 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
Roche Holding AG, already advancing multiple therapies and diagnostics for COVID-19, is adding its support for Boston-based Atea Pharmaceuticals Inc.'s AT-527 to the lineup.
Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir).
Keeping you up to date on recent developments in diagnostics, including: Study underscores long-term impact of COVID-19; CT scan enhancement via deep learning; Caution in screening for large fetus size.
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